Silagen Silicone Gel Sheeting

GUDID 00816465020626

7120 Silagen Beige Silicone Areola, 2 7/8” dia. (7.2cm dia.), 2 pcs/package

Newmedical Technology, Inc.

Scar-management dressing, reusable
Primary Device ID00816465020626
NIH Device Record Key3e2a1d52-d3e1-4114-a0c5-1b34dabc2132
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilagen Silicone Gel Sheeting
Version Model Number7120
Company DUNS787828669
Company NameNewmedical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com
Phone847-412-1000
Emailregulatory@newmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816465020626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-15
Device Publish Date2025-08-07

On-Brand Devices [Silagen Silicone Gel Sheeting]

008164650208177390 Silagen Clear Silicone Belly Button, 0.54" dia. (1.4cm dia.), 1 pc/package
008164650208007370 Silagen Clear Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package
008164650207947170 Silagen Beige Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package
008164650207257380 Silagen Clear Silicone Dots, 1” dia. (2.5cm dia.), 6 pcs/package
008164650207187180 Silagen Beige Silicone Dots, 1” dia. (2.5cm dia.), 6 pcs/package
008164650207017328 Silagen Clear Silicone Breast Kit, 2 pcs Areola & 2 pcs Anchor/package
008164650206957128 Silagen Beige Silicone Breast Kit, 2 pcs Areolas & 2 pcs Anchors/package
008164650206887326 Silagen Clear Silicone Anchor, 10”x4 1/8” (25.4x10.5cm), 2 pcs/package
008164650206717126 Silagen Beige Silicone Anchor, 10”x4 1/8” (25.4x10.5cm), 2 pcs/package
008164650206647324 Silagen Clear Silicone Lollypop, 2 7/8”x6 1/2” (7.2x16.4cm), 2 pcs/package
008164650206577304 Silagen Clear Silicone Strips, 1"x6" (2.5x15.2cm), 4 pcs/package
008164650206407124 Silagen Beige Silicone Lollypop, 2 7/8”x6 1/2” (7.2x16.4cm), 2 pcs/package
008164650206337320 Silagen Clear Silicone Areola, 2 7/8” dia. (7.2cm dia.), 2 pcs/package
008164650206267120 Silagen Beige Silicone Areola, 2 7/8” dia. (7.2cm dia.), 2 pcs/package
008164650206197301 Silagen Clear Silicone Sheet, 5"x6" (12.7x15.2cm), 1 pc/package
008164650205967104 Silagen Beige Silicone Strips, 1"x6" (2.5x15.2cm), 4 pcs/package
008164650205897333 Silagen Clear Silicone Strips, 1"x3" (2.5x7.6cm), 3 pcs/package
008164650205727101 Silagen Beige Silicone Sheet, 5"x6" (12.7x15.2cm), 1 pc/package
008164650204117364 Silagen Clear Silicone Abdomen Sheet, 2"x24" (5.1x61.0cm), 1 pc/package
008164650204047164 Silagen Beige Silicone Abdomen Sheet, 2"x24” (5.1x61.0cm), 1 pc/package
008164650203987363 Silagen Clear Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package
008164650203817163 Silagen Beige Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package
008164650203747360 Silagen Clear Silicone Abdomen Sheet, 2"x8" (5.1x20.3cm), 1 pc/package
008164650203677160 Silagen Beige Silicone Abdomen Sheet, 2"x8" (5.1x20.3cm), 1 pc/package

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.